Pharmaceutical Technology, Jan 2, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, Jan 2, 2011
Online Exclusives
Improving the Quality of Product Release
By Michael Goetter , Jeremy Tanner
The authors discuss the role of quality-control automation in providing better data, enhanced compliance, and potentially faster release times.
How to Effectively Manage a Product Recall
By Nancy Cafmeyer , Jonathan M. Lewis
The authors group key actions to consider when conducting a product recall and discuss how to execute them carefully and thoroughly.
Colloids Book Helps and Confuses the Reader
By Todd L. Cecil
Poor organization makes it hard for readers to find the helpful information in a recent book.
Special Report
Outlook 2011
By Patricia Van Arnum
Industry executives share insight into the future direction of drug manufacturing and the supply chain. This article contains online bonus material.
FDA Discusses Current and Future Take on Compliance
By Angie Drakulich
Industry executives share insight into the future direction of drug manufacturing and the supply chain.
Preventing and Troubleshooting Manufacturing Deviations
By Angie Drakulich
Industry experts offer their best practices for dealing with deviations. This article contains online bonus material.
Special Feature
Manufacturing Techniques of Orally Dissolving Films
By Renuka Mishra , Avani Amin
The manufacture of orally dissolving films is done by various methods such as solvent casting, hot-melt extrusion, semisolid casting, solid-dispersion extrusion, and rolling. The authors discuss these methods and the various parameters in which dissolving films are evaluated.
Peer-Reviewed
FDA Perspectives: An Initial Report of CDER's Recall Root Cause Research Project (Part II)
By Richard L. Friedman , Michael Smedley , Lynn D. Torbeck , Israel Santiago
The authors discuss how their research will help FDA in its identification of areas of emphasis in pre- and postapproval evaluation of products and processes.
A Comparison of Three Extrusion Systems
By Amelie Desire , Bruno Paillard , Joel Bougaret , Michel Baron , Guy Couarraze
The authors conducted an experiment to determine the type of extrusion that provides the best productivity and pellet quality. This article contains online bonus material.
From The Editor
What a Piece of Work is Pharma
By Michelle Hoffman
Capable of great works, pharma as a whole still yields to the lesser angels of its nature.
PharmTech Talk
Build Your Own Vaccine Facility
By Erik Greb
New modular bioprocessing technology could quicken the response to an outbreak of disease.
Agent-in Place
Here's to Second Chances
By Control
Multiple attempts and do-over approaches should eventually solve the problem at stake.
News
Report from Europe
By Sean Milmo
The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.
Global Healthcare on the Ground: Global Health Progress Initiative
By Angie Drakulich
The Global Health Progress collaboration works to improve healthcare delivery in the developing world.
In the Spotlight
In the Spotlight
A look at manufacturing products in process control.
Washington Report
Cost and Compliance Dominate Agenda for 2011
By Jill Wechsler
Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.
BioForum
Next-Generation Therapeutics on the Horizon
By G. Steven Burrill
Developments in RNAi, monoclonal antibodies, and more are boosting the biotech marketplace.
Ingredients Insider
Exploring Custom Synthesis
By Patricia Van Arnum
Contract manufacturers strengthen their toolboxes and partnerships as they navigate the changing drug-development model.
Inside ICH
Inside ICH: ICH Meets in Japan to Finalize Key Documents
By Moheb Nasr , Robert Baum
Expert and implementation working groups harmonize more guidelines and move Q11 forward.
Outsourcing Outlook
What to Watch for in 2011
By Jim Miller
CDMOs and CMOs face weak economic recovery, consolidation, and globalization.
Industry Leaders
Q&A with Tony MacDonald, Spectrum
A Q&A with Spectrum Laboratories President Tony MacDonald.
Viewpoint
The US Drug Supply Chain: Safety Must be Paramount
By Robert Billings
Holding product and supply-chain security to the highest standards is crucial for the future.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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